Pilot Study to Explore the Integrated Personalized Functional Profiling (PFP) for Cancer Patients With Metastatic Gastrointestinal Cancer (mGIC) or Recurrent Glioblastoma (rGBM) in Luxembourg
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 4
- 主要终点
- Number of patients for which a treatment recommendation for their specific cancer can be formulated, based on PFP
研究概览
简要总结
The investigators are developing a novel standardized and centralized approach named Integrated Personalized Functional Profiling (PFP) in Luxembourg. Based on recent improvements in cancer biopsy-derived 3D-culture technologies the PFP process will screen patient derived cells (PDCs) with FDA/EMA-approved drugs to generate personalized functional response profiles. The selected drug through PFP technology will provide personalized treatment recommendation for the patient.
This pilot study will evaluate the clinical feasibility of setting-up an effective workflow as a first step. Outcomes from this study will be used subsequently to help plan the clinical validation of the implementation of PFP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with recurrent Glioblastoma (rGBM) or with metastatic gastrointestinal cancer (mGIC), i.e. adenocarcinoma (any grade) of stomach, liver, pancreas, small intestine, colon, rectum
- •The patient has received previous cancer treatment for mGIC or rGBM
- •Male or female ≥ 18 years
- •Life expectancy ≥ 12 weeks
- •Histologically or cytologically confirmed diagnosis for mGIC or recurrence of a glioblastoma, WHO grade IV
- •For women of childbearing potential, a negative pregnancy test documented prior to the screening visit is required
- •Signed Inform Consent Form before any study related procedure
排除标准
- •For female patient, being pregnant, planning a pregnancy or breastfeeding
- •No fresh and viable tumor material available
- •Known active Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection
- •Uncontrolled medical conditions (i.e, diabetes mellitus, hypertension, etc), psychological, familial, sociological, or geographical conditions that do not allow compliance with the protocol; or unwillingness or inability to follow the procedures required in the protocol
- •In mGIC arm, patient with non-adenocarcinoma gastrointestinal cancer
- •Patient unable to understand and consent himself
结局指标
主要结局
Number of patients for which a treatment recommendation for their specific cancer can be formulated, based on PFP
时间窗: 4 weeks
次要结局
- Number of drugs recommended by using the PFP approach(4 weeks)
- Quantity of cells needed for the PFP analysis(4 weeks)
- Duration of the PFP process for one specific patient(4 weeks)
- Number of patients for which the treatment recommendation issued by PFP were followed by the investigator(4 weeks)